Triple Antibiotic

Triple Antibiotic
SPL v1
SPL
SPL Set ID 26bd5ba4-264b-2a28-e063-6394a90ada80
Route
TOPICAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [USP'U]) Neomycin (5 mg) Polymyxin B (5000 [iU])
Inactive Ingredients
White Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-12

Description

Active Ingredients (in each gram) Purpose Bacitracin Zinc 400 units ................................................................................................................................................................................................................... First Aid Antibiotic Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin) ......................................................................................................................................... First Aid Antibiotic Polymyxin B Sulfate 5000 units ..................................................................................................................................................................................................... First Aid Antibiotic


Medication Information

Warnings and Precautions

For External Use Only

Do not use In the eyes or apply over large areas of the body If you are allergic to any of the ingredients Longer than 1 w eek unless

directed by a doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if The condition persists or get worse A rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1

to 3 times daily. May be covered with a sterile bandage.

Dosage and Administration

Active Ingredients (in each gram) Purpose

Bacitracin Zinc 400 units ................................................................................................................................................................................................................... First Aid Antibiotic

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin) ......................................................................................................................................... First Aid Antibiotic

Polymyxin B Sulfate 5000 units ..................................................................................................................................................................................................... First Aid Antibiotic

Description

Active Ingredients (in each gram) Purpose Bacitracin Zinc 400 units ................................................................................................................................................................................................................... First Aid Antibiotic Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin) ......................................................................................................................................... First Aid Antibiotic Polymyxin B Sulfate 5000 units ..................................................................................................................................................................................................... First Aid Antibiotic

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive Ingredient White Petrolatum

Section 51945-4

Section 55105-1

... First Aid Antibiotic


Structured Label Content

Indications and Usage (34067-9)

Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1

to 3 times daily. May be covered with a sterile bandage.

Dosage and Administration (34068-7)

Active Ingredients (in each gram) Purpose

Bacitracin Zinc 400 units ................................................................................................................................................................................................................... First Aid Antibiotic

Neomycin Sulfate 5 mg (equivalent to 3.5 mg Neomycin) ......................................................................................................................................... First Aid Antibiotic

Polymyxin B Sulfate 5000 units ..................................................................................................................................................................................................... First Aid Antibiotic

Warnings and Precautions (34071-1)

For External Use Only

Do not use In the eyes or apply over large areas of the body If you are allergic to any of the ingredients Longer than 1 w eek unless

directed by a doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if The condition persists or get worse A rash or other allergic reaction develops

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive Ingredient White Petrolatum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

... First Aid Antibiotic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)